Ekr Therapeutics, Inc.

Ekr Therapeutics, Inc. Drugs

• Retavase
  

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  Retavase

  

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  Retavase® (Reteplase) is for intravenous administration only. Retavase® is administered as a 10 + 10 unit double-bolus injection. Two 10 unit bolus injections are required for a complete treatment. Each bolus is administered as an intravenous injection over 2 minutes. The second bolus is given 30 minutes after initiation of the first bolus injection. Each bolus injection should be given via an intravenous line in which no other medication is being simultaneously injected or infused. No other medication should be added to the injection solution containing Retavase®. There is no experience with patients receiving repeat courses of therapy with Retavase®. Heparin and Retavase® are incompatible when combined in solution. Do not administer heparin and Retavase® simultaneously in the same intravenous line.

  If Retavase® is to be injected through an intravenous line containing heparin, a normal saline or 5% dextrose (D5W) solution should be flushed through the line prior to and following the Retavase® injection.

  Although the value of anticoagulants and antiplatelet drugs during and following administration of Retavase® has not been studied, heparin has been administered concomitantly in more than 99% of patients. Aspirin has been given either during and/or following heparin treatment. Studies assessing the safety and efficacy of Retavase® without adjunctive therapy with heparin and aspirin have not been performed.

  Reconstitution – Retavase® Kit and Retavase® Half-Kit: Reconstitution should be carried out using the diluent and dispensing pin provided with Retavase®. It is important that Retavase® be reconstituted only with the supplied Sterile Water for Injection, USP (without preservatives). The reconstituted preparation results in a colorless solution containing Retavase® 1 unit/mL. Slight foaming upon reconstitution is not unusual; allowing the vial to stand undisturbed for several minutes is usually sufficient to allow dissipation of any large bubbles.

  Because Retavase® contains no antibacterial preservatives, it should be reconstituted immediately before use. When reconstituted as directed, the solution may be used within 4 hours when stored at 2-30°C (36-86°F). Prior to administration, the product should be visually inspected for particulate matter and discoloration.

  Reconstitution Instructions – Retavase® Kit and Retavase® Half-Kit: Use aseptic technique throughout.

  Step 1:        Withdraw 10 mL of Sterile Water for Injection, USP (SWFI) from the supplied vial into a sterile 10 mL syringe. Step 2:        Open the package containing the dispensing pin.        Remove the protective cap from the luer lock port of the dispensing pin and connect the sterile 10mL syringe to the dispensing pin.        Remove the protective flip-cap from one vial of Retavase ®. Step 3:        Remove the protective cap from the spike end of the dispensing pin, and insert the spike into the vial of Retavase ® until the security clips lock onto the vial.        Transfer the 10 mL of SWFI through the dispensing pin into the vial of Retavase ®. Step 4:        With the dispensing pin and syringe still attached to the vial, swirl the vial gently to dissolve the Retavase ®. DO NOT SHAKE. Step 5:        Withdraw 10 mL of Retavase ® reconstituted solution back into the syringe. A small amount of solution will remain in the vial due to overfill. Step 6:        Detach the syringe from the dispensing pin, and attach a sterile needle. Step 7:        The 10 mL bolus dose is now ready for administration.        Safely discard all used reconstitution components and the empty Retavase ® vial according to institutional procedures.

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• Cardene I.v.
  

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  Cardene I.v.

  

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  2.1 Recommended Dosing

  Cardene I.V. is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

  Dosage as a Substitute for Oral Nicardipine Therapy

  The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

  Oral Cardene Dose Equivalent I.V. Infusion Rate 20 mg q8h 0.5 mg/hr = 2.5 mL/hr 30 mg q8h 1.2 mg/hr = 6 mL/hr 40 mg q8h 2.2 mg/hr = 11 mL/hr

  Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

  Initiate therapy at 25 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 12.5 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 75 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved.

  Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 15 mL/hr (3 mg/hr).

  Drug Discontinuation and Transition to an Oral Antihypertensive Agent

  Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

  If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.

  If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

  Special Populations

  Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.3, 5.4 and 5.5)]

  2.2 Monitoring

  The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

  Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment. If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 15-25 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure.

  2.3 Instructions for Administration

  Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.6)].

  Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

  Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

  Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

  Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

  Preparation for administration

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

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• Cardene I.v.
  

  ×

  Cardene I.v.

  

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  2.1 Recommended Dosing

  Cardene I.V. is intended for intravenous use. Titrate dose to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.

  Dosage as a Substitute for Oral Nicardipine Therapy

  The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:

  Oral Cardene Dose Equivalent I.V. Infusion Rate 20 mg q8h 0.5 mg/hr = 5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr

  Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine

  Initiate therapy at 50 mL/hr (5.0 mg/hr). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15.0 mg/hr), until desired blood pressure reduction is achieved.

  Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr).

  Drug Discontinuation and Transition to an Oral Antihypertensive Agent

  Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

  If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of Cardene I.V. Premixed Injection.

  If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion.

  Special Populations

  Titrate Cardene I.V. Premixed Injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.3, 5.4 and 5.5)].

  2.2 Monitoring

  The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

  Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment. If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of Cardene I.V. Premixed Injection may be restarted at low doses such as 30-50 mL/hr (3.0 - 5.0 mg/hr) and adjusted to maintain desired blood pressure.

  2.3 Instructions for Administration

  Administer Cardene I.V. by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.6)].

  Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is required.

  Inspect Cardene I.V. Premixed Injection visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check the container for minute leaks prior to use by squeezing the bag firmly; ensure that the seal is intact. If leaks are found, discard solution as sterility may be impaired. Cardene I.V. Premixed Injection is normally a clear, colorless to yellow solution.

  Do not combine Cardene I.V. Premixed Injection with any product in the same intravenous line or premixed container. Do not add supplementary medication to the bag. Protect from light until ready to use.

  Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

  Preparation for administration

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

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